Evaluation of false positive rate based on exposure-response analyses for two compounds in fixed-dose combination products

Journal of Pharmacokinetics and Pharmacodynamics

Volumn 38, Issue 6, 2011, Pages 671-696

  Zhu, Hao ^a   Wang, Yaning ^a  

^a CDER   (United States)

Author keywords

Exposure response analysis; Fixed dose combination products; Type I error

Indexed keywords

ANALYTICAL ERROR; ARTICLE; CONCENTRATION RESPONSE; CONTROLLED STUDY; DRUG DETERMINATION; EXPOSURE VARIABLE; FALSE POSITIVE RESULT; LOGLINEAR MODEL; MATHEMATICAL COMPUTING; MATHEMATICAL MODEL; MULTIVARIATE ANALYSIS; PRIORITY JOURNAL; RESPONSE VARIABLE; SIMULATION; STRUCTURE ANALYSIS; UNIVARIATE ANALYSIS;

CLINICAL TRIALS AS TOPIC; COMPUTER SIMULATION; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG COMBINATIONS; FALSE POSITIVE REACTIONS; HUMANS; MODELS, STATISTICAL; RESEARCH DESIGN;

EID: 84855700659     PISSN: 1567567X     EISSN: 15738744     Source Type: Journal    
DOI: 10.1007/s10928-011-9214-4     Document Type: Article

References (8)

1. Code of Federal Regulation Title 21, Volume 5, Section 300.50
2. Corbett AH, Lim ML, Kashub AD (2002) Kaletra (Lopinavir/Ritonavir). Ann Pharmacother 36(7-8):1193-1203
3. Goicoechea M, Best B (2007) Efavirenz/emtricitabline/tenofovir disoproxil fumarate fixed-dose combination: First-line therapy for all? Expert Opin Pharmacother 8(3):371-382
4. Wang Y, Bhattaram AV, Jadhav PR, Lesko LJ, Madabushi R, Powell JR, Qiu W, Sun H, Yim DS, Zheng JJ, Gobburu JV (2008) Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: Impact of FDA pharmacometrics during 2004-2006. J Clin Pharmacol 48(2):146-156
5. Bhattaram VA, Bonapace C, Chilukuri DM, Duan JZ, Garnett C, Gobburu JV, Jang SH, Kenna L, Lesko LJ, Madabushi R, Men Y, Powell JR, Qiu W, Ramchandani RP, Tornoe CV, Wang Y, Zheng JJ (2007) Impact of pharmacometric reviews on new drug approval, labeling decisions-a survey of 31 new drug applications submitted between 2005 and 2006. Clin Pharmacol Ther 81(2):213-221 (Pubitemid 46174818)
6. Lockwood PA, Cook JA, Ewy WE, Mandema JW (2003) The use of clinical trial simulation to support dose selection: Application to development of a new treatment for chronic neuropathic pain. Pharm Res 20(11):1752-1759 (Pubitemid 37449447)
7. Beak IH, Yun MH, Yun HY, Kwon KI (2008) Pharmacokinetic/pharmacodynamic modeling of the cardiovascular effects of beta blockers in humans. Arch Pharm Res 31(6):814-821
8. Garnett CE, Beasley N, Bhattaram VA, Jadhav PR, Madabushi R, Stockbridge N, Tornoe CW, Wang Y, Zhu H, Gobburu JV (2008) Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review. J Clin Pharmacol 48(1):13-18 (Pubitemid 350292272)